SPRIX Drug Patent Profile

Which patents cover Sprix, and what generic alternatives are available?

Sprix is a drug marketed by Zyla and is included in one NDA.

The generic ingredient in SPRIX is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sprix

A generic version of SPRIX was approved as ketorolac tromethamine by MYLAN on May 16^th, 1997.

Summary for SPRIX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	97
Patent Applications:	4,765
Drug Prices:	Drug price information for SPRIX
What excipients (inactive ingredients) are in SPRIX?	SPRIX excipients list
DailyMed Link:	SPRIX at DailyMed

See drug prices for SPRIX

Pharmacology for SPRIX

Drug Class	Cyclooxygenase Inhibitor Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Paragraph IV (Patent) Challenges for SPRIX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SPRIX	Nasal Spray	ketorolac tromethamine	15.75 mg/spray	022382	1	2012-03-12

US Patents and Regulatory Information for SPRIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zyla	SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382-001	May 14, 2010		RX	Yes	Yes

Expired US Patents for SPRIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Zyla	SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382-001	May 14, 2010
Zyla	SPRIX	ketorolac tromethamine	SPRAY, METERED;NASAL	022382-001	May 14, 2010

International Patents for SPRIX

See the table below for patents covering SPRIX around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	0524587
Japan	H05194215	THERAPEUTIC COMPOSITION FOR NARIAL ADMINISTRATION CONTAINING 5-BENZOYL-2,3-DIHYDRO-1H-PYRROLIDINE- 1-CARBOXYLIC ACID
European Patent Office	0524587	Compositions thérapeutiques pour l'administration intranasale contenant ketorolac R. (Therapeutic compositions for intranasal administration which include ketorolac TM.)
Austria	130758
Spain	2082288
Italy	1250691	COMPOSIZIONI TERAPEUTICHE PER SOMMINISTRAZIONE INTRANASALE COMPRENDENTI KETOROLAC.

Supplementary Protection Certificates for SPRIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	CA 2015 00072	Denmark		PRODUCT NAME: OKULAER SKYLLEVAESKE OMFATTENDE PHENYLEPHRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HYDROCHLORID OG KETOROLAC ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1534313	2015/071	Ireland		PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	C 2015 055	Romania		PRODUCT NAME: COMBINATIE DE FENILEFRINA SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTEIA SI KETOROLAC SATIONAL AUTHORISATION: 20150728; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1018; DATE OF FIRST AUTHORISATION IN EEA: 20150728 U O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1018; DATE OF NA
1534313	15C0090	France		PRODUCT NAME: SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1018 20150728

SPRIX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SPRIX (Ketorolac Tromethamine) Nasal Spray

Introduction

SPRIX (ketorolac tromethamine) Nasal Spray is a prescription non-steroidal anti-inflammatory drug (NSAID) designed for the short-term management of moderate to moderately severe pain, offering analgesia at the opioid level without the use of opioids. Here, we delve into the market dynamics and financial trajectory of SPRIX since its introduction.

Approval and Initial Launch

SPRIX was approved by the U.S. Food and Drug Administration (FDA) in May 2010 for the short-term management of moderate to moderately severe pain. It was launched by Regency Therapeutics, a division of Luitpold Pharmaceuticals, Inc., in collaboration with Daiichi Sankyo, Inc.[1].

Market Positioning

SPRIX entered the market as a unique offering, providing opioid-level pain relief without the risks associated with opioid use. This positioning was crucial given the growing concern over opioid abuse and the need for non-narcotic pain management options. The drug is particularly useful in settings where rapid pain relief is necessary, such as in hospitals, emergency medicine treatment centers, and surgical facilities[1].

Marketing and Distribution

Initially, Regency Therapeutics' specialty sales force marketed SPRIX to hospitals, emergency medicine treatment centers, surgeons, and other specialists. Additionally, Luitpold’s Osteohealth division targeted dentists, oral surgeons, and periodontists. Daiichi Sankyo, Inc. promoted SPRIX to primary care physicians through a co-promotion agreement[1].

Acquisition by Egalet

In January 2015, Egalet Corporation acquired SPRIX from Luitpold Pharmaceuticals for $7 million. This acquisition was part of Egalet's strategy to transform into a fully integrated specialty pharmaceutical company focused on pain management. Egalet also licensed OXAYDO, an immediate-release oxycodone product designed to deter abuse, further expanding its pain treatment portfolio[2].

Commercial Expansion

Under Egalet, SPRIX saw significant commercial expansion. Egalet built a dedicated sales force targeting pain medicine physicians, primary care physicians, nurse practitioners, orthopedic surgeons, and neurologists. By the end of the first quarter of 2017, Egalet's sales force was promoting SPRIX to approximately 4,500 healthcare providers. Additional partnerships with Ascend Therapeutics and OraPharma further broadened the reach to include women’s healthcare providers and dental specialists[3].

Financial Impact

The acquisition and commercialization of SPRIX contributed to Egalet's revenue growth. The transactions, including the acquisition of SPRIX and the licensing of OXAYDO, were funded through a $15 million debt financing with Hercules Technology Growth Capital. These moves helped Egalet achieve commercial-stage status two years ahead of plan and established a commercial presence to support the launch of other pipeline products[2].

Sales Performance

Egalet's efforts to promote SPRIX led to increased adoption among healthcare providers. By targeting a wide range of practitioners, Egalet was able to drive revenue growth for SPRIX. The company reported that SPRIX, along with other products like OXAYDO and ARYMO ER, contributed to its overall revenue growth and helped in building a robust commercial infrastructure[3].

Reformulation and Patent Life

Egalet has been working on reformulating SPRIX to improve its performance and extend its patent life. This initiative aims to add new intellectual property and potentially enhance the product's market position. The reformulation plans were set to be detailed in mid-2018, indicating ongoing efforts to maintain and grow SPRIX's market presence[3].

Competitive Landscape

SPRIX competes in the short-term analgesic market, which is highly competitive. However, its unique positioning as a non-opioid, opioid-level pain reliever sets it apart. Studies have shown that SPRIX can reduce morphine use by patients in post-operative settings, making it a valuable option in the fight against opioid abuse[3].

Regulatory and Safety Considerations

Like other NSAIDs, SPRIX comes with important safety information, including warnings about gastrointestinal, bleeding, cardiovascular, and renal risks. These considerations are crucial for healthcare providers when prescribing SPRIX, and Egalet has emphasized the importance of educating providers about these risks as part of its marketing efforts[1].

Key Takeaways

• Unique Market Position: SPRIX offers opioid-level pain relief without the use of opioids, addressing a critical need in pain management.
• Commercial Expansion: Egalet's acquisition and marketing efforts significantly expanded SPRIX's reach to various healthcare providers.
• Financial Contribution: SPRIX has been a key contributor to Egalet's revenue growth and commercial success.
• Ongoing Development: Efforts to reformulate SPRIX aim to improve its performance and extend its patent life.
• Competitive Advantage: SPRIX's ability to reduce morphine use in post-operative settings makes it a valuable option in the short-term analgesic market.

FAQs

Q: What is SPRIX used for? A: SPRIX (ketorolac tromethamine) Nasal Spray is used for the short-term management of moderate to moderately severe pain that requires analgesia at the opioid level.

Q: Who initially launched SPRIX? A: SPRIX was initially launched by Regency Therapeutics, a division of Luitpold Pharmaceuticals, Inc., in collaboration with Daiichi Sankyo, Inc.

Q: How does SPRIX differ from other pain relief medications? A: SPRIX is a non-opioid NSAID that provides opioid-level pain relief, making it a unique option in the market.

Q: Who acquired SPRIX in 2015? A: Egalet Corporation acquired SPRIX from Luitpold Pharmaceuticals in January 2015.

Q: What are the safety considerations for SPRIX? A: SPRIX comes with warnings about gastrointestinal, bleeding, cardiovascular, and renal risks, similar to other NSAIDs.

Sources

1. Daiichisankyo.com: Regency Therapeutics and Daiichi Sankyo Announce Launch and Commercial Availability of SPRIX® (ketorolac tromethamine) Nasal Spray.
2. Globenewswire.com: Egalet Acquires/Licenses Two Innovative Approved Pain Products.
3. Edgar-online.com: Egalet Corp (Form: 10-K, Received: 03/16/2018 08:19:57).